Padagis Nitroglycerin Lingual Spray Recalled Due to a Potential Defective Delivery System
On December 27, 2021, the United States Food & Drug Administration announced a voluntary, national recall of Padagis Nitroglycerin Lingual Spray. According to the recall announcement, the product’s dispensing unit is defective and does not “properly dispense medication.” Padagis US LLC also announced that the recall was conducted out of an abundance of caution since there is a small risk that the Nitroglycerin Lingual Spray may not correctly administer medication to patients in the event of a malfunction of the product’s dispensing unit. The recall only applies to the 12g spray bottle of the medication.
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12 g
- Lot #s: 150892, 153199, and 156041
- Expiration Dates: Oct 2022, Feb 2023, and Apr 2023
The recall’s official Risk Statement says that if the product fails to deliver the proper amount of nitroglycerin, the patient will presumably continue to feel chest pain. If the patient does not feel relief after three doses in a 15 minutes period of time, the patient needs to seek prompt medical attention. At the time of this article’s publication, Padagis stated that it had not received any adverse event reports related to this recall.
Nitroglycerin Lingual Spray is meant to quickly relieve an attack or prophylaxis of chest ache caused by coronary artery disease in adult patients. The affected product is packaged in a 12 g bottle held within a box. This medication was distributed throughout the United States to retailers and wholesalers.
Padagis has notified its customers and distributors by express package delivery service and email and is making arrangements to return all affected Nitroglycerin Lingual Spray. All customers, consumers, and healthcare providers are instructed to inspect their medication inventory for the recalled bottle of Nitroglycerin Lingual Spray, 12g, immediately quarantine, stop the distribution, and use.
Sedgwick Claims Management Services is providing healthcare providers and customers with recall information. All buyers who have distributed this product to consumers were asked to identify consumers and inform them instantly of the product recall. Healthcare distributors, providers, and retailers who have recalled products should not distribute the products. Patients using the product should contact their doctor for an alternate medication before returning the affected product.
Patients are urged to contact their physician should they experience any side effects. Quality issues and adverse reactions encountered with the recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting program online, or download form regular mail or by fax.
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